Home NDC 53746-460 Ibuprofen
Product NDC 53746-460
11-digit product format 537460460
Labeler code 53746
Product ID 53746-460_0a178197-17b9-4e74-a85b-abd0ba469966
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA079233
Marketing category ANDA
Marketing start 2013-04-30
Substance IBUPROFEN
Active strength 200 mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079233-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 2014-03-18
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079233-001 IBUPROFEN 200MG TABLET / ORAL 2014-03-18 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310965 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53746-460-02 Ibuprofen 250 in 1 BOTTLE TABLET 250 5 53746-460-10 Ibuprofen 1000 in 1 BOTTLE TABLET 1000 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-460 IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 5 Current NDC, Legacy NDC, 2 package rows 20240101_59f14d2b-f48a-4c25-bea3-3dc9100898b2.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53746-460-02 53746046002 250 TABLET in 1 BOTTLE (53746-460-02) 250 tablet 2013-04-30 0000-00-00 No No Current 53746-460-10 53746046010 1000 TABLET in 1 BOTTLE (53746-460-10) 1000 tablet 2013-04-30 0000-00-00 No No Current